Taking Advantage of the EU MDR Delay in Uncertain Times – Webinar
Overview
Where
Online Webinar
When
10 AM ET
Why Attend?
Dental medical device manufacturers are facing mounting regulatory pressure — not only under EU MDR, but also through increasing scrutiny from regulators and reviewers in other key markets. Clinical evaluation requirements have become more rigorous, demanding stronger scientific justification, systematic methodology, and comprehensive documentation.
Join Celegence for this expert-led webinar to examine real-world strategies for achieving regulatory compliance and audit-ready clinical documentation — all tailored to the unique challenges of dental devices.
The session is delivered by clinical and regulatory experts with deep experience of supporting dental device manufacturers. You’ll have the opportunity to join a live Q&A and take away actionable insights for your next clinical evaluation.
Celegence is hosting the webinar on Thursday, June 26th at 10 AM ET. Register now!
Who Should Attend?
This webinar is designed for those responsible for the technical documentation of dental medical devices, including:
- Regulatory affairs professionals
- Clinical affairs professionals
- Manufacturers of dental medical devices
- Persons responsible for technical files
Reserve Your Spot
This is your opportunity to hear directly from regulatory professionals who support dental device manufacturers daily.
All registrants will receive a recording of the webinar after the live session.
Register today and strengthen your clinical evaluation strategy.
What You Will Learn
The session is delivered by clinical and regulatory experts with deep experience of supporting dental device manufacturers. You’ll have the opportunity to join a live Q&A and take away actionable insights for your next clinical evaluation. Celegence is hosting the webinar on Thursday, June 26th at 10 AM ET. Register now!
- Global regulatory readiness: explore how different regions — including the EU, U.S., and international markets — are converging on higher standards for clinical evaluation and what that means for dental devices.
- Responding to Notified Bodies and Regulatory Authorities: gain insights into the most common observations and deficiencies identified during reviews of Clinical Evaluation Plans and Reports, and how to address them effectively.
- Smarter Documentation Through Technology: see how technology platforms can help streamline the development of consistent, high-quality documentation across regions.
- Varied Clinical Evaluation Strategies and Approaches: Learn how to tailor your clinical evaluation methodology to different types of dental devices — from legacy products to innovative technologies — and align them with current regulatory expectations.
- Post-Market Clinical Follow-Up (PMCF): understand how to determine when PMCF is needed — and how to justify your strategy based on risk, intended use, and state-of-the-art.
- Future-Proofing Compliance: Stay ahead of evolving global regulatory expectations and learn how to position your dental device portfolio for long-term market access.
Webinar Speakers
Manager – Medical Device Services, Celegence
Priya Ray Chaudhuri,
Priya Ray Chaudhuri is an expert in clinical affairs with over a decade of experience in medical writing, clinical evaluation, and post-market surveillance for medical devices. As a manager at Celegence, she oversees global regulatory projects, ensuring alignment with EU MDR, IVDR, MEDDEV 2.7.1 Rev 4, and country-specific requirements. Priya brings deep expertise in authoring and reviewing clinical and performance evaluation reports, PMCF plans, PMS reports, and PSURs across a wide spectrum of therapeutic areas. Beyond documentation, Priya supports strategic decision-making by providing regulatory intelligence, training cross-functional teams, and leading high-value proposal development. Her client-centric mindset, backed by deep technical expertise, ensures consistently successful submissions and long-term regulatory success.
Senior Medical Writer, Celegence
Dr. Manaswitha Boyanagari
Dr. Manaswitha is a Dentist, with a master's degree in public health. She has 8 years of experience in clinical and public health research. She has authored and reviewed EU MDR compliant regulatory documents (CEP, CER, PMS Report, PMCFER, etc.) for medical devices covering a wide range of therapeutic areas. At Celegence, she is the author and reviewer for clinical evaluation and post-market surveillance documents for medical devices. She also serves as a clinical Subject Matter Expert for dental medical devices.
Where
Online Webinar
When
10 AM ET
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25 Apr, 2025
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